Method of designing orthopedic implants using in vivo data

ABSTRACT

A reconfigurable orthopedic implant trial comprising: (a) a first orthopedic component; (b) a second orthopedic component that includes a second sensor on a second articulating surface thereof, the second orthopedic component configured to removably mount to the first orthopedic component; (c) a third orthopedic component that includes a third sensor on a third articulating; surface thereof, the third orthopedic component configured to removably mount to the first orthopedic component, where the second sensor and the third sensor are configured to generate kinematic data.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. Nonprovisional application Ser.No. 12/348,285, filed Jan. 3, 2009, titled “METHOD OF DESIGNINGORTHOPEDIC IMPLANTS USING IN VIVO DATA,” which claimed the benefit ofU.S. Provisional Application Ser. No. 61/046,512, filed Apr. 21, 2008,and U.S. Provisional Application Ser. No. 61/199,545, filed Nov. 18,2008, the disclosures of each of which are hereby incorporated byreference.

RELATED ART

1. Field of the Invention

The present invention is directed to orthopedic implants and methods ofdesigning orthopedic implants using in vivo data specific to anorthopedic implant or orthopedic trial. Specifically, the instantinvention may utilize permanent orthopedic implants and orthopedictrials (collectively, “implants”) outfitted with pressure sensors toprovide in vivo feedback regarding the position and magnitude ofpressures exerted upon the devices to discern which design(s) ispreferable.

2. Brief Discussion of Related Art

Orthopedic knee replacement systems are currently developed based onarthropometric studies of average bone shape, visual examination of usedorthopedic implants, and simulated knee systems using computer aideddesign (CAD) software. In addition, orthopedic implants failures areexamined by implant designers, which may result in design changes madeto the proposed CAD orthopedic implant design(s). The resulting CADdesigns are then manipulated by the CAD software to generate simulateddata as to the kinematics of the artificial joint and possible weardata. But at no time are the proposed orthopedic implant designs testedin vivo to determine kinematics and the actual forces exerted upon thejoint through its range of motion. Accordingly, prior art methods ofdesigning orthopedic implants have suffered from the limitationsassociated with CAD software models to accurately predict periarticularforces, kinematics, and constraints.

Every arthritic natural knee undergoing total knee arthroplasty (TKA)has different muscle, tendon, and ligamentous abnormalities. Inaddition, different approaches for TKA release different ligamentousstructures that also affect the periarticular knee forces andkinematics. But when modeling the knee using CAD software, theprogrammer must make considerable and likely erroneous boundaryconditions to model periarticular structures. The instant inventionaddresses some of these shortcomings by gathering in vivo data directlyfrom actual orthopedic implants using the same bone cuts that would bemade during a knee replacement procedure. In this manner, the in vivodata objectively identifies to orthopedic designers which proposedimplant design has the best kinematics and pressure distributions. Also,abnormally high forces on vulnerable implant features (e.g., a tibialinsert post) can be determined prior to permanent implant failure.Accordingly, proposed orthopedic implant designs can be prioritized andfurther refined before adopting a preferred orthopedic implant design.In addition to using in vivo data to design and/or refine orthopedicimplants, the instant invention also allows this in vivo data to beutilized to construct mathematical and CADCAM software models simulatingand accurately reflecting natural movements of body parts. Accordingly,future modeling of orthopedic components may not utilize in vivo datadirectly, but rather rely on software modeled using actual in vivo data.

INTRODUCTION TO THE INVENTION

The present invention is directed to orthopedic implants and methods ofdesigning orthopedic implants using in vivo data specific to theorthopedic implant or orthopedic trial. Specifically, the instantinvention utilizes permanent orthopedics and orthopedic trials(collectively, “implants”) outfitted with sensors (such as pressuresensors, accelerometers, vibration sensors, sound sensors, ultrasonicsensors, etc.) to provide feedback regarding the position of theimplants, as well as the positions and magnitudes of pressures exertedupon the implants, when moved through an in vivo range of motion todiscern which design(s) is preferable. In addition, permanentorthopedics and orthopedic trials (collectively, “implants”) outfittedwith sensors may provide feedback about contact area measurementsthroughout the range of movement of the prosthetic joint to, inexemplary form, ensure that contact areas are sufficient to decreasestresses and reduce wear between the contact surfaces of the joint. Inother words, greater contact areas between joint components movingagainst one another generally translates into loads applied to the jointbeing less concentrated, thereby reducing wear associated with thecontacting surfaces, such as polyethylene tibial tray inserts, forexample.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevated perspective view of an exemplary stereolithographytibial tray trial;

FIG. 2 is an exploded view of an exemplary stereolithography femoraltrial and stereolithography tibial tray insert trial;

FIG. 3 is another exploded view of the exemplary stereolithographyfemoral trial and the stereolithography tibial tray insert trial of FIG.2;

FIG. 4 is an exemplary pressure sensor array for use in the instantinvention;

FIG. 5 is a pictorial representation of a computer screen showing howphysical pressures, contact areas, magnitudes, and distributions on anexemplary tibial tray insert trial are displayed;

FIG. 6 is an exemplary pressure sensor for use in the instant invention;

FIGS. 7A-7F are various views showing bone cuts to the tibia and femurduring a knee arthroplasty procedure; and

FIG. 8 is an elevated perspective view showing how a patient's tibia maybe modified to receive a tibia tray;

FIG. 9 is an elevated perspective view showing how the tibia tray ofFIG. 8 would accept a tibia tray insert;

FIG. 10 is an elevated perspective view showing how the patient's femurwould receive a femoral implant;

FIG. 11 includes interior views of several complimentary right and leftexemplary femoral trials having differing sizes;

FIGS. 12A-12D are elevated perspective views of several exemplary tibialtray insert trials;

FIG. 13 is a frontal view of an exemplary tibial tray insert trial andtibial tray trail in accordance with the instant invention;

FIG. 14 is a profile view of the exemplary tibial tray insert trial andtibial tray trail of FIG. 13;

FIG. 15 is an overhead view of an exemplary tibial tray insert trial inaccordance with the instant invention;

FIG. 16 is a profile view of several exemplary tibial tray insert posttrials in accordance with the instant invention;

FIG. 17 is an exemplary pressure sensor array for use in the instantinvention;

FIG. 18 are frontal views of a series of exemplary condyle receiverinserts for a tibial tray insert trial in accordance with the instantinvention;

FIG. 19 is a frontal view of an exemplary tibial tray trial, includingtibial shim shown in phantom, in accordance with the instant invention;

FIG. 20 is a profile view of an exemplary tibial tray trial includingtibial shims in accordance with the instant invention;

FIG. 21 is a distal view of an exemplary femoral trial in accordancewith the instant invention;

FIG. 22 is a profile view the femoral trial of FIG. 21, with a pair ofcondyle inserts;

FIG. 23 is a profile view the femoral trial of FIG. 21, with a differentpair of condyle inserts;

FIG. 24 is a profile view the exemplary condyle insert of FIG. 22;

FIG. 25 is a profile view the exemplary condyle insert of FIG. 23;

FIG. 26 is a distal view of another exemplary femoral trial inaccordance with the instant invention;

FIG. 27 is a profile view the femoral trial of FIG. 26, with a series ofcondyle inserts;

FIG. 28 is a profile view the exemplary condyle inserts of FIG. 26;

FIG. 29 is a frontal view of an exemplary femoral trial;

FIG. 30 is a profile view of the exemplary full femoral trial of FIG.29;

FIG. 31 is a frontal view of the exemplary full femoral cam and box ofFIGS. 29 and 30;

FIG. 32 is a frontal view of an exemplary tibial tray insert trial andtibial tray trial, where the tibial tray insert post is rotatable;

FIG. 33 is a profile view of an exemplary tibial tray insert trial andtibial tray trial, where the tibial tray insert post is rotatable;

FIGS. 34 and 35 are exemplary tibial tray insert posts for use with thetibial tray insert trials in FIGS. 32 and 33; and

FIGS. 36-39 are profile fluoroscopic images of an orthopedic kneeimplant at discrete points through a knee bend or range of motion.

DETAILED DESCRIPTION

The exemplary embodiments of the present invention are described andillustrated below to encompass methods of designing, selecting, andmanufacturing orthopedic implants, as well as the resulting orthopedicimplants themselves, in addition to methods to improve softwaresimulations using actual in vivo data. Of course, it will be apparent tothose of ordinary skill in the art that the embodiments discussed beloware exemplary in nature and may be reconfigured without departing fromthe scope and spirit of the present invention. However, for clarity andprecision, the exemplary embodiments as discussed below may includeoptional steps, methods, and features that one of ordinary skill shouldrecognize as not being a requisite to fall within the scope of thepresent invention.

Referencing FIGS. 1-3, several orthopedic stereolithography (SLA) trials10, 12, 14 are shown that in combination would comprise a trial kneejoint orthopedic replacement. As used within the instant disclosure,“trial” refers to a proposed design of a tangible orthopedic implantfabricated to an actual size and shape, but that has not yet receivedFDA approval and/or is not intended to be implanted permanently. Thoseskilled in the art are familiar with orthopedic knee joint replacementsand knee joint replacement trials that are commonly fabricated fromvarious materials such as, without limitation, polymers, ceramics, andmetals. For purposes of explanation only, a permanent knee jointreplacement is generically referred to herein as an orthopedic jointreplacement, which commonly includes a femoral component 10, a tibialtray insert component 12, and a tibial tray component 14. Nevertheless,it is to be understood that the exemplary methods discussed below areapplicable to designing and selecting any other orthopedic jointreplacement component such as, without limitation, those components foruse in shoulder and hip replacements.

Prior art techniques for developing orthopedic implants typicallyinvolve utilization of computer aided design (CAD) software. Typical CADsoftware allows an orthopedic implant designer to change virtuallyanything related to the size and shape of the implant. CAD software hasevolved to include artificial generation of kinematic data and pressuredata based upon an electronic simulation of how the designed orthopediccomponents will interface with one another during a range of movement.This simulated data is used to narrow the possibilities for a preferredorthopedic design, resulting in several designs typically emerging. Atthis point in the design process, orthopedic designers construct SLAmodels/trials of the preferred design elements, usually from plastics.These trials are not for permanent implantation, but are fabricated toshow the designers the actual size and shape of the implants beforemanufacture of the permanent version. It is important to note that theconfiguration of these prior art SLA models is fixed and that anygeometric differences that exist between multiple orthopedic designsmandates fabrication of completely new SLA models. The designers arriveat an optimal design consensus typically without any testing of SLA's invivo. Rather, the designers agree on the final design and authorizefabrication of the final implant (manufactured out of the finalmaterials), which is ultimately implanted in patients for study underIRB approval. At this point in the design process, some modificationscan be made to the permanent design based on the experience of surgeonsboth intraoperatively and postoperatively, but any such modificationswould be very minor.

Prior art design techniques would rarely, if ever, take the various SLAtrials, implant them in place of the normal joint, and take thereplacement joint through a range of motion. To the extent any SLAtrials are taken through a range of motion, only qualitative assessmentsare made by orthopedic designers and consulting surgeons. Ultimately,one combination of the SLA trials (femoral, tibial tray, tibial trayinsert) is selected as the overall best design for the new orthopedicknee system. But such a design approach relies solely on the artificialpredictions of the CAD software and qualitative assessments of thedesigners and surgeons, without ever measuring in vivo pressures exertedby the implants upon one another. In direct contrast, the instantinvention uses actual in vivo pressure and kinematic data to design andoptimize an orthopedic joint and its corresponding components.

The method of the instant invention may make use of CAD software toinitially design one or more fixed orientation orthopedic implants fortrialing. Unlike prior art methods, the instant method obtains actual invivo pressure and kinematic data showing how the trials interact withone another. It should also be understood that other forms of data maybe gathered in addition to or in lieu of pressure data such as, withoutlimitation, fluoroscopic data, X-ray data, accelerometer data, vibrationdata, sound data, and ultrasonic data. In other words, the instantmethod constructs SLA models/trials of orthopedic components (such as afemoral component, a tibial tray component, and a tibial tray insertcomponent) using CAD software inputs. After the SLA trials have beenfabricated, each trial is outfitted with one or more sensors, such aspressure sensor arrays, on those surfaces or embedded within the trialsthat will physically contact one another.

Referring to FIG. 4, an exemplary commercially available pressure sensorarray or grid 16 is available from Novel gmbh, Munich, Germany(www.Novel.de). An example of a commercially available grid 16 fromNovel gmbh is the S2015 sensor grid that comprises two spaced apartsensor matrices having 16×8 pressure sensors 18. A single connector 20provides an output data interface from both sensor grids that is adaptedfor connection to a computer and associated software for transmittingpressure and magnitude data from each sensor on the grid to a visualdisplay associated with the computer.

Referencing FIG. 5, a computer 22 includes a software program availablefrom Novel gmbh that is operative to use the data output from eachsensor 18 by way of the connector 20 to reproduce a virtual sensor gridon the computer screen 24. This reproduction provides a color-codedvisual grid with multiple rectangles corresponding to the sensors. Eachrectangle visually represents, in real-time, the magnitude of pressureexerted upon each sensor or adjacent group of sensors by way of colorand a numerical read-out. As shown in FIG. 5, each condyle receiver ofthe tibial tray insert trial 12 includes a corresponding one of the 16×8pressure sensor arrays 16. Thus, when pressure is applied either or bothcondyle receivers, the computer screen 24 depicts which sensors aredetecting pressures greater than atmospheric pressure (i.e., ambientconditions). In this manner, an observer of the computer screen 24 isable to discern precisely the magnitude and location of pressuresexerted upon the tibial tray insert trial 12.

Referring to FIG. 6, another available sensor for use with the instantinvention is the Model 060 3-lead miniature pressure transducer 30available from Precision Measurement Company, Ann Arbor, Mich.(http://www.pmctansducers.com). This transducer is fabricated fromstainless steel and provides the availability to measure pressures fromzero to two-thousand pounds per square inch. In exemplary form, a seriesof Model 060 transducers are mounted to a backer material (not shown),to maintain the orientation of the transducers in a predeterminedconfiguration, which is externally mounted to an SLA trial and exposedto sense pressures. In an alternate exemplary embodiment, the Model 060transducers are embedded within the SLA trials. These predeterminedconfigurations have been matched to the wirings of the transducers tocorrelate the electrical signal output from the transducer arrayaccording to the position and configuration of the transducers. In thismanner, one can obtain transducer output signals that are representativeof both pressure and position. The output signals are then interpretedby a signal processor and utilized by software to construct a positionalspreadsheet that numerically changes in real-time corresponding to thepressures detected by each transducer. As a result, pressure datachanges as a function of time and orthopedic implant position arerecorded.

Referring back to FIGS. 2 and 3, each femoral trial 10 includes a pairof condyles 40, 42 that engage corresponding condyle receivers 44, 46associated with the tibial tray insert trial 12. In exemplary form, eachcondyle 40, 42 is outfitted with a pressure sensor grid 16 (see FIG. 4)from Novel gmbh so that the surfaces of each condyle 40, 42 coming intocontact with the condyle receivers 44, 46 of the tibial tray inserttrial 12 will include corresponding pressure sensors. In this manner, asthe femoral condyles 40, 42 are rotated in vivo through their range ofmovement with respect to the tibial tray insert trial 12, data is outputfrom the sensor arrays 16 providing quantitative information as to thelocation and magnitude of pressures exerted upon the femoral trialsurfaces. Moreover, by knowing the pressures exerted upon the sensorgrids, contact areas can be determined throughout the range of motion.This contact area data may be particularly helpful in identifying areasof the trials that receive heightened stresses and correspondinglydesigning these areas with reinforcement or changing the design toincrease contact areas. In addition to outfitting the femoral condyleswith sensors, the tibial tray insert trial 12 may also be outfitted witha pressure sensor array (not shown), where the sensor array covers thecondyle receivers 44, 46. But before the orthopedic trials 10, 12, 14may be implanted and in vivo data taken, several steps must occur toprepare the patient's native tissue.

As discussed in U.S. Pat. No. 4,787,383, the disclosure of which ishereby incorporated by reference, several cuts are made to the nativefemur and tibia to shape these bones for reception of the orthopediccomponents. Referencing FIGS. 7A-7F, the distal end 70 of the femur 72is reshaped by making a series of angled blocked cuts, while theproximal end 74 of the tibia 76 is cut off to leave a generally planarsurface exposing the tibial canal (not shown). After these bone cutshave been made, the bones are further prepared to receive the tibial andfemoral trials. In exemplary form, these preparations include reamingthe tibial canal and predrilling fastener holes within the femur. Thoseskilled in the art are familiar with the techniques necessary to preparenative tissue to receive orthopedic trials and implants.

Referring to FIGS. 8-10, after the patient's femur is prepared to accepta femoral trial 80 on the distal end of the femur 82 and the patient'stibia is prepared to accept a tibial tray 84 on the proximal end of thetibia 86, the respective instrumented SLA trials are secured to thefemur and tibia.

Referring to FIGS. 11 and 12A-12D, in accordance with the instantinvention, the surgeon has at his disposal several different femoraltrials 80A-80J, a tibial tray trial 14 (see FIG. 1), and a plurality oftibial tray insert trials 81A-81D, where each trial or selected trialsmay be outfitted with sensors. Exemplary sensors for use with the trialsinclude, without limitation, pressure sensors, accelerometers, vibrationsensors, ultrasonic sensors, and sound sensors.

In exemplary form, after a set of orthopedic trials are implanted, asurgeon takes the orthopedic trials through a range of motion similar tothat of a normal knee. As the trial orthopedic knee joint is movedthrough its range of motion, in vivo sensor data is generated from eachof the respective sensor grids associated with the orthopedic trials.This sensor data is useful to determine which SLA trial combination ispreferred by looking at: 1) medial and lateral compartment pressuremagnitudes—to insure they do not exceed the material properties orvalues that might increase wear or lead to implant loosening; 2) medialand lateral compartment contact areas throughout the range of motion—toinsure they remain comparable to minimize the stresses throughout therange of motion and to avoid known abnormal loading patters such as edgeloading or point contact or liftoff (complete loss of contact area); 3)medial and lateral compartment pressure distributions—to insure thatnormal knee kinematics are occurring (e.g., rollback, internal tibialrotation with flexion, etc) from reviewing the exact orientation of thefemoral component relative to the tibial component; and, 4) dynamicpressure magnitude, distribution, and kinematics to be compared todynamic databases in the computer interface. Exemplary dynamic databasesinclude, without limitation, normal pre-operative kinematic data, normalpost-operative kinematic data, abnormal pre-operative kinematic data,and abnormal post-operative kinematic data.

Orthopedic SLA trials can vary in many significant ways. For example,tibial tray insert trials could vary by post location (medial or lateralor anterior of posterior), post orientation, rotation, and shape(height, width, angles), condyle receiver shape (depth, angle, length),tray thickness, and whether the tray is fixed or mobile bearing.Likewise, the femoral trial could vary by the shape of the J-curve, camlocation, cam orientation, radii of curvature of the condyles, thicknessof the condyles, spacing between the condyles, coronal geometry, andvarying the foregoing between the medial and lateral trials. Asdiscussed above, SLA trials include fixed geometric features resultingfrom their unitary construction. Instead of fabricating and testing aplethora of fixed geometry SLA trials, the instant invention may alsomake use of reconfigurable trials that allow for geometricalreconfiguration.

Referring to FIGS. 13-16, a reconfigurable tibial tray insert 90includes an arrangement of orifices 98, with at least one of theorifices 98 to receive a dowel 100 of a corresponding tibial tray insertpost 102. The arrangement of orifices 98 allows the position of the post102 to be changed in between trial implantations to see how changes inthe position of the post affect contact pressures and kinematics of theartificial joint. Specifically, the arrangement of orifices 98 includeorifices that are centered and offset from the medial-lateralcenterline. In addition, one or more of the orifices 98 may be centeredor offset from the anterior-posterior centerline. In exemplary form, theorifices 98 are electronically mapped and each orifice is given aspecific reference corresponding to its location. For example, theorifice most anterior and lateral is given the designation A, with theanterior-posterior direction contributing a reference letter (“A” forexample) that is incremented sequentially from anterior to posteriorbased upon the distance from the A reference orifice. In addition, themedial-lateral direction contributes a reference number (“1” forexample) that is incremented sequentially from medial to lateral basedupon the distance from the 1 reference orifice. In this manner, anorifice positioned at the farthest anterior and farthest medial mighthave a reference A1, while an orifice at the farthest posterior andfarthest lateral might have a reference Z26. In other words, the firstorifice medial from the A1 orifice is designated A2, while the firstorifice posterior from the A1 orifice is designated B1. In the exemplarytibial tray insert trial 90 shown in FIG. 15, the orifices 98 may bedesignated C13, T13, K7, K19. It should also be understood that incertain circumstances the tibial tray insert 90 will not include a post102, particularly where a cruciate retaining tray insert is implanted.

Referring specifically to FIGS. 15 and 16, a plurality of removabletrial posts 102 may be used with the reconfigurable tibial tray insert90. Each post 102 includes a contoured top 104 attached to a cylindricaldowel 100 that is adapted to be received within one of the orifices 98of the reconfigurable tibial tray insert 90. Depending upon thepreference of the surgeon/physician, the dowel 100 may be locked toinhibit rotation with respect to the tibial tray insert 90, or may beallowed to freely rotate or rotate within a predetermined range. Thoseskilled in the art will be knowledgeable as to the plethora of devicesthat one might use to bring about this functionality including, withoutlimitation, set screws. In addition, as will be discussed in more detailbelow, it is also within the scope of the invention to includes orifices98 shaped other than cylindrically, as well as dowels shaped other thancylindrically (see FIGS. 15 and 16). In this exemplary line-up, thedowels 100 perpendicularly extend from each contoured top 104. It shouldbe noted, however, that the dowels may be oriented at angles other thanninety degrees and that the dowels may be reconfigurably angled usingset screws (not shown) between serial joints (not shown) incorporatedwithin the dowel 100. Those skilled in the art will also understand thatshims may be added to the underside of each post to vary the height ofthe post within a Z-axis. While several exemplary shaped posts 102 areshown, it is to be understood that other exemplary shaped posts could beutilized and all such alternative designed posts fall within the scopeand spirit of the present invention.

Referring to FIGS. 16 and 17, each trial post 102 is outfitted with asensor array 110 so that dynamic pressure data may be generated fromcontact between the post and the femoral trial. An exemplary sensorarray for use with the post trials includes, without limitation, anS2014 pressure sensor array from Novel gmbh (www.Novel.de). Because eachorifice 98 of the tibial tray insert trial is identified by a uniqueidentifier, as is each post trial, when a particular post trial 102 istested in vivo, the location of the post, identification of the post,height of the post, and angle of the post can be easily recorded inconjunction with the pressure data generated by the sensor array 110. Inthis manner, a surgeon can choose from various trial posts 102 and learnhow changes in the shape of the contoured top 104, changes in the angleof the top (by way of the angled dowel 100), changes in the height ofthe contoured top 104, and changes in the location of the trial post 102affect pressures exerted within the artificial joint and jointkinematics. Likewise, each trial post 102 may be outfitted one or moreof the following sensors or arrays of sensors: accelerometers, vibrationsensors, ultrasonic sensors, and sound sensors. In addition, or in thealternative, the patients natural tissue may be outfitted (internally orexternally) with one or more of the following sensors or arrays ofsensors to gather data during the course of tissue ranges of movement:accelerometers, vibration sensors, ultrasonic sensors, and soundsensors.

It is also within the scope of the invention to include fluoroscopicdata acquisition and/or X-ray data acquisition when repositioningorthopedic implants or trials in vivo. Those skilled in the art arefamiliar with fluoroscopy and X-rays, as well as devices utilized totake and record fluoroscopic images and X-ray images. Specifically, thefluoroscopic images and X-ray images are, in exemplary from, taken froma profile view of a joint and oriented on a split screen so that asurgeon and/or joint designer, for example, can see the movement of thejoint in vivo in addition to pressure and positional measurements takenin a time matching display. Accordingly, any anomalies evident fromeither display can be evaluated with a second set of data atapproximately the same time as the anomaly. In other words, numericaldata from one or more sensors is time matched with pictorial data toallow concurrent qualitative and quantitative analysis.

Referencing FIG. 15, it is also within the scope of the invention toinclude orifices 98 within the tibial tray insert trial 90 that are notcylindrical in shape. By way of example, and not limitation, an orifice98 may be shaped to receive a spline dowel (not shown). In such acircumstance, the rotational position of the post trial could be varied,but fixed for purposes of in vivo data gathering. Other orifices 98could exhibit a hexagonal shape to receive a corresponding hexagonaldowel. In addition, orifices 98 could be star-shaped (see FIG. 15),rectangular, or triangular to receive a star-shaped (see FIG. 16),rectangular, or triangular dowel 100. Those skilled in the art willreadily understand the variations in dowel shape and correspondingcavity shape that will allow rotational position adjustability of thepost trial 102.

Referring to FIGS. 13-16 and 18, the reconfigurable tibial tray insert90 includes a right side bay 92 and a left side bay 94 that receivecorresponding condyle receiver inserts 96. In exemplary form, aplurality of condyle receiver inserts 96 are removably mounted to thereconfigurable tibial tray insert 90 using one or more prongs 97 thatare received within cavities 99 formed within the tray insert 90. Eachreceiver insert 96 embodies a different shape to enable the surgeon tosee how shape of the condyle receivers affects joint pressures andkinematics. Each of the stock condyle receiver inserts 96 may bemanipulated using filament shims (not shown) that are adhered to thecondyle receivers. Exemplary filament shims include, without limitationplastics, metals and/or ceramics. In this fashion, the condyle receiversmay be readily reconfigured to change the depth, angle, and lengthwithout requiring fabrication of a completely new tibial tray trial.After the condyle receivers have been built up in the selected areas,presuming this is done at all, a sensor grid may be applied to thesurfaces of the condyle receivers to be contacted by the femoralcondyles. In this manner, the sensors associated with the condylereceivers 96 will provide output data as to the location and magnitudeof pressures exerted between the trials during in vivo joint range ofmotion.

By using the above reconfigurable tibial tray insert 90, a series ofcondyle receiver inserts 96 may be fabricated having various geometries(e.g., coronal and sagittal) to provide interchangeability for quickexchange of condyle receivers. For example, a first exemplary condylereceiver insert may have a deep groove that includes an arcuateposterior segment and a linear sloped posterior segment. Obviously,those skilled in the art will readily understand the various designalternatives one might conceive for the shape of a condyle receiver,which could be separately fabricated ahead of time or on the fly forready insertion into the tibial tray insert trial 90.

Referencing FIGS. 19 and 20, the reconfigurable tibial tray insert trial90 may be mounted to tibial tray shims 106, 107 mounted to the tibialtray 108 to vary the orientation of the tray insert 90 (see FIG. 13).The 106, 107 shims might also be made to vary in thickness from anteriorto posterior or to vary the slope as well as medial to lateral. Aplethora of tray shims may be manufactured at predetermined thicknesses,where one or more of the shims are stackable to provide the ability touse multiple shims to increase the thickness of the tibial tray inserttrial for in vivo testing. Each shim would include its own uniqueidentifier so that one would be able to quickly discern the thickness ofthe tibial tray insert trial without requiring measuring.

Referring to FIGS. 21-25, a first reconfigurable femoral trial 120includes a right condyle cutout 122 and a left condyle cutout 124, whereeach cutout 122, 124 may include a cavity, projection, or other featureadapted to interact with a condyle insert 128, 128′ to mount the condyleinsert 128 to the femoral trial 120. In this first exemplary femoraltrial 120, the right condyle cutout 122 and the left condyle cutout 124each include a pair of cavities 130 that each receive a correspondingprojection 132 of a condyle insert 128.

Two exemplary condyle inserts 128, 128′ are shown that exhibit variancesin size and shape. By way of example, and not limitation, a firstcondyle insert 128 exhibits a first J-curve, while a second exemplarycondyle insert 128′ exhibits a second J-curve. Obviously, those skilledin the art will readily understand the various design alternatives onemight conceive for the shape of a condyle, which would be separatelyfabricated ahead of time for ready insertion into the overall femoraltrial. These condyle inserts 128, 128′ are removably mounted to thecondyle cutouts 122, 124 to construct the femoral trial 120. Presumingthe surgeon is satisfied with the size and shape of the condyles, eachcondyle may be outfitted with an exterior sensor array 110 (see e.g.,FIG. 17) so that dynamic pressure data may be generated from contactbetween the condyles and corresponding condyle receivers of the tibialtray insert trial. An exemplary sensor array for use with the condylesincludes, without limitation, an S2014 sensor array from Novel gmbh(www.Novel.de). In exemplary form, the sensor array is oriented ontoeach condyle using a reference mark (not shown) on the condyle tostandardize the position of the sensor array with respect to thecondyles. In this manner, data from the sensor array may be correlatedto positional data to show precisely where on the condyles pressureswere detected and in what magnitude during in vivo range of motion ofthe artificial joint.

Referring to FIGS. 26-28, a second reconfigurable femoral trial 140includes multiple medial condyle cutouts 142, 144, 146 and lateralcondyle cutouts 148, 150, 152 where each cutout includes a pair ofcavities 154 is adapted to receive a corresponding projection 156 of acondyle insert 158. The exemplary condyle inserts 158 (including inserts158A, 158B, and 158C) may exhibit variances in size and shape. By way ofexample, and not limitation, an anterior condyle 158A insert may exhibita slightly curved contour, while a more posterior condyle insert 158Cmay exhibit a more pronounced curvature, particular at toward theposterior end. Obviously, those skilled in the art will readilyunderstand the various design alternatives one might conceive for theshape of a condyle, which would be separately fabricated ahead of timefor ready insertion into the overall femoral trial 140. These condyleinserts 128 are removably mounted to the condyle cutouts 142-152 toconstruct the femoral trial 140. Presuming the surgeon is satisfied withthe size and shape of the condyles, each condyle may be outfitted with asensor array 110 (see FIG. 17) so that dynamic pressure data may begenerated from contact between the condyles and corresponding condylereceivers of the tibial tray insert trial. An exemplary sensor array foruse with the condyles includes, without limitation, an S2014 sensorarray from Novel gmbh (www.Novel.de). In exemplary form, the sensorarray is oriented onto each condyle using a reference mark (not shown)on the condyle to standardize the position of the sensor array withrespect to the condyles. In this manner, data from the sensor array maybe correlated to positional data to show precisely where on the condylespressures were detected and in what magnitude during in vivo range ofmotion of the artificial joint.

Alternatively, the shape of the stock condyles may be manipulated usingfilament shims (not shown). In exemplary form, the condyles may bereadily reconfigured to change the width, J-curve shape, and anglewithout requiring fabrication of a completely new femoral trial. Afterthe shape of the condyles reach a desired shape using the filamentshims, an array of pressure sensors is adhered to the exterior of thecondyles where the condyles will contact the tibial tray insert trialduring the range of movement of the femoral trial. As discussed above,an exemplary sensor array for use with the condyles includes, withoutlimitation, an S2014 sensor array from Novel gmbh (www.Novel.de).

Referring to FIGS. 29-31, it is also within the scope of the inventionto allow a femoral trial 160 to accept various trial inserts 162, 164.In exemplary form, a plurality of cam trial inserts 162 with differingshapes and sizes are available to mount to the generic tunnel 166 toprovide cams at various positions along the J-curve. In a preferredembodiment, each cam trial insert 162 includes its own uniqueidentification and each mounting location of the generic tunnel includesits own unique identification. Accordingly, one can vary the size of thecam, the shape of the cam, as well as its mounting position to thetunnel 166, and track its interactions with the tibial trial post todetermine aspects such as, without limitation, how the location of thecam effects rollback of the femoral trial. Each cam trial insert 162 isoutfitted with a pressure sensor array so that contact with the postgenerates dynamic sensor data during in vivo testing of the trials. Asdiscussed above, an exemplary sensor array for use with the cam trialinsert 140 includes, without limitation, an S2014 sensor array fromNovel gmbh (www.Novel.de). Thus, the reconfigurable femoral trial 160provides shape and positional variance of a cam trial insert 162 alongsubstantially the entire J-curve. Because the locations of the mountingpoints for the cam trial insert 162 on the tunnel 166 are predeterminedand each cam trial insert 162 includes its own unique identification,when a particular cam trial insert is tested in vivo, the location ofthe cam and its identification can be easily recorded to correlate thepressure data taken as a function of location. Similarly, a plurality ofbox trial inserts 164 with differing shapes and sizes are available tomount to the femoral trial 160 to provide boxes having predeterminedconfigurations (i.e., widths, lengths, depth, curvature 167, etc.). In apreferred embodiment, each box trial insert 164 includes its own uniqueidentification. Accordingly, one can vary the size of the box and theshape of the box and track its interactions with the tibial trial postto determine aspects such as, without limitation, how the location ofthe box effects rollback of the femoral trial. Each box trial insert 164may be outfitted with a pressure sensor array so that contact with thepost generates dynamic sensor data during in vivo testing of the trials.Because each box trial insert 164 includes its own uniqueidentification, when a particular box trial insert is tested in vivo,its identification (and associated unique geometric features) can beeasily recorded to correlate the pressure data taken as a function oflocation.

Referencing FIGS. 32-35, the principles of the instant invention arealso applicable to trails having mobile bearing features. In exemplaryform, a mobile bearing tibial trial 200 includes a tibial tray trial202, a tibial tray insert trial 204, and a tibial post trial 206. Theexemplary tibial tray insert trial includes a pair of bays 208 adaptedto receive inserts 210 providing a particular shape for each condylereceiver. A through hole 212 is provided in the tibial tray insert trialto accommodate insertion and rotation of the tibial post 206. A cavity214 is provided within the tibial tray to accommodate a distal end ofthe tibial post 206. The orientation of the hole 212, as well as theorientation of the cavity 214, allow the post 206 to rotate 360 degrees.In exemplary form, sensors (not shown) are mounted to the exposedportions of the condyle receiver inserts 210 and the exposed portion ofthe post 206 that provide pressure feedback when the trial 200 isimplanted and put through a range of motion. In like manner, the tibialpost 106 may be exchanged for another post 106′ exhibiting differentgeometric features, implanted, and in vivo data taken to discern howchanges in geometry affect pressures, kinematics, and wearcharacteristics. This same concept is also applicable to the condylereceiver inserts 210.

For purposes of brevity, only a single exemplary mobile bearing exampleis discussed herein. From the instant disclosure, however, those skilledin the art will readily understand the applicability of these principlesto other mobile bearing prosthetic components. In this manner, theinstant invention is not limited to mobile bearing trials for use withtotal knee arthroplasty. For example, the instant invention may beapplied to hip and shoulder arthroplasty procedures to facilitate designand selection of the appropriate prosthetic on a patient-specific orclass-specific basis.

The ability to intraoperatively adjust the geometric configuration ofthe trials in order to gather sensor data from those trials outfittedwith sensors, while using the same femoral and tibial bone cuts,provides the orthopedic designer (by way of the surgeon) with theability to ascertain how specific femoral and tibial trial designmodifications effect the kinematics of the orthopedic joint andpressures exerted upon the orthopedic joint elements during in vivorange of movement. For example, by changing the position of the post ofthe tibial tray insert, the designer is able to see how this changeimpacts knee kinematics and contact points between the femoral componentand tibial tray insert. Exemplary repositioning of the tibial trayinsert post position includes movement in the anterior-posterior and themedial-lateral directions and rotation.

While the foregoing orthopedic trials have been explained in terms ofsensor arrays or grids that are external to the orthopedic trials, it isalso within the scope of the invention to utilize sensors that areinternal to the orthopedic trials. Internal sensors and sensor arrayshave been disclosed in co-pending U.S. patent application Ser. No.11/890,307, entitled “SMART JOINT IMPLANT SENSORS,” the disclosure ofwhich is hereby incorporated by reference. While the foregoingincorporated disclosure addresses internal sensors for permanentorthopedic implants, the same teachings could be easily applied toorthopedic trials.

As discussed above, the tibial tray insert trial and femoral trial maybe instrumented with sensors to measure relative pressure magnitudes anddistributions of the relative tibiofemoral contact positions. It is alsowithin the scope of the invention to utilize other sensors such as,without limitation, accelerometers, vibration sensors, ultrasonicsensors, and sound sensors. The data generated by the sensor arraysassociated with the trials is dynamic, thereby generating data setacross the entire range of movement of the orthopedic trials reflectingboth the position of the pressures and the magnitude of the pressures.In this manner, the data may reflect any changes in the location andmagnitude of the pressures exerted upon the orthopedic trials as afunction of change in position of the trials along their range ofmotion. In addition, this dynamic data can be manipulated to generatetibiofemoral kinematic data used to construct a computer 3-D modelshowing how the trial components were moving with respect to one anotherintraoperatively. When pressure sensors are utilized, the centralcontact point for each pressure distribution is determined for eachcompartment and then the relative positions of the femoral and tibialimplants with respect to one anther are determined by the computerinterface in real time during range of motion trialing. Each data set(sensor pressure data including magnitude as a function of position &kinematic data) may then be compared to a database having similar datasets for normal knees, as well as analogous data sets for patientsalready having a total knee arthroplasty procedure.

In exemplary form, the comparison of patient data occurs electronicallywithin an artificial neural network (“ANN”). ANN may be comprised ofsoftware or a combination of software and hardware. For example, ANN mayinclude a plurality of simple processors each connected by communicationchannels carrying data. Whether ANN comprises only software or acombination of software and hardware, the software includes a trainingrule to correlate the importance of certain connections between data.This training rule may be hard programmed or soft programmed by theprogrammer when correlating certain data and giving the correlated dataa particular grade on a fixed scale.

Exemplary data from patient cases to be correlated might include,without limitation: (1) orthopedic implant data for particular designs;(2) patient specific data such as race, gender, height, weight, and age;(3) in vivo orthopedic pressure and/or kinematic data from trials takenduring a range of movement; (4) pre-operative (from modeling and finiteelement testing) and post-operative kinematic data for the particularorthopedic implant; and (5) limb mechanical axis data; (6)arthropometric patient specific data (from pre-operative x-rays and/orCT or MRI 3-D reconstructions) showing the size and shape of theoriginal tibia and femur bones with the desire to match this morphologywith the implants (so as not to oversize or undersize or stuff gaps withmore implant than bone than anatomically present or intraoperativelyremoved). By correlating the patient-specific data with data from otherpatient cases having a positive to exceptional outcome, ANN is able tocompare the aforementioned data prospectively (with the exception ofpost-operative kinematic data) for each patient and predict whether apreexisting orthopedic design would be preferred. ANN also providesguidance to a designer looking for potential design modifications tocurrent designs as well as a starting point for unique orthopedicimplant designs.

By way of example, and not limitation, ANN records how specific trialmodifications affect pressure magnitudes, distributions, contact areas,and kinematics. In exemplary form, a surgeon implants a series of trialcombinations and takes each combination through its range of motion,with ANN recording the results. While the surgeon is contemplatingfurther combinations of trials, ANN provides predictive feedback to thesurgeon suggesting which of the possible combinations of trials would beadvantageous to try. Alternatively, ANN suggests to the surgeon areas ofpossible modification and the extent of the modification when usingreconfigurable trials. In this manner, ANN reduces the number oftrialings needed to arrive at an optimal or preferred design.

Referring to FIG. 36-39, development of normal knee kinematic databasesmay be accomplished by subjecting a number of patients to a fluoroscopeor X-ray machine while performing deep knee bends or passive range ofmotion that reproduces trialing. The resulting output from thefluoroscope and X-ray machine provides data showing how the tibia moveswith respect to the femur during a deep knee bend and passive range ofmotion. Generally speaking, as the normal knee is moved from an extendedposition to a bent position, the distal portion of the femur rolls withrespect to the proximal portion of the tibia so that the contact pointbetween the femur and tibial actually moves anterior-to-posterior. Inaddition, both condyles of the normal knee rotate laterally as the kneeis bent (tibia internally rotates with flexion). Simply put,fluoroscopic data and X-ray data from normal knees provides a dynamicdatabase showing kinematic movement of the knee joint over its normalrange of motion. In addition, each normal patient data set may includeadditional information on the patient's gender, age, race, weight, etc.in order to facilitate ready classification and more accuratecomparisons with in vivo orthopedic trial data. It is envisioned thatorthopedic implants could be designed specifically for each patient, butit is also within the scope of the invention to design more genericimplants that might be classified using gender, age, race, and/orweight.

A comparison of the in vivo (i.e., intraoperative) trial data andpatient data from the database may be carried out by a human or may beautomated by a computer program. When automated, a computer programcompares the intraoperative trial data, and possibly the trial kinematicdata, to a series of data sets taken from patients with normal kneesand/or earlier patients having a total knee arthroplasty (TKA)procedure. For those patients having a TKA procedure, intraoperativedata was taken using trials outfitted with pressure sensors that matchedthe permanent orthopedic implant. Each patient data set was data takenintraoperatively using trials outfitted with pressure sensors to measurethe contact pressures and generate data as to the magnitude, locationand distribution and contact area of the pressures when the trials wereput through a range of motion. Follow-up data was taken on each patientso that the intraoperative data is supplemented with post-operativedata. Generally, on the order of a few months after TKA, fluoroscopicdata and/or X-ray data was taken after surgery of the actual implantsthrough a range of movement. This fluoroscopic data is dynamic data andallows one to construct a 3-D representation of the actual implant todetermine such things as whether abnormal condylar lift off isoccurring, whether the translation occurring between the tibial andfemoral components are normal such that the normal tibial internalrotation with flexion is occurring (25 degrees is normal from 0-125degrees), normal posterior rollback is occurring with flexion as presentin the normal knee: patellofemoral interactions are normal (patellatracking normally): whether in mobile bearing TKA the rotation withflexion (25 degrees is normal from 0-125) is occurring at the tibialinsert undersurface (normal) or at the main articulation (abnormal).Using this comparison of sensor and kinematic data, an optimalorthopedic design could be derived for a given patient, and aftermultiple optimal configurations are determined an optimal design fordifferent patients could be ascertained (best design for male, bestdesign for female, best design for obese, etc).

After an optimal orthopedic design has been chosen and proved from invivo data in accordance with the instant invention, prior art techniquesfor fabricating orthopedic implants may be followed. Alternatively, theinstant method envisions fabricating orthopedic implants in asubstantially real-time basis. To do so, the surgeon would implant aplurality of trials and gather in vivo data. This data would then becompared to a database in substantially real-time to discern which trialprovided the best kinematic and pressure results. The surgeon wouldchoose which orthopedic trials provided the patient with the best fitand accordingly forward fabrication instructions to a rapidmanufacturing machine. Exemplary rapid manufacturing machines include,without limitation, the Sinterstation HiQ Series SLS System availablefrom 3D Systems Corporation, Rock Hill, S.C. (www.3dsystems.com).Thereafter, the end orthopedic implant would be rapid manufactured basedupon the fixed data already programmed for each trial. In other words,each trial is preprogrammed into the rapid manufacturing machine so thatupon receiving the appropriate signal, the rapid manufacturing machinewould fabricate the orthopedic implant.

Advantageously, if the surgeon were using the reconfigurable trials ofthe instant invention, the opportunity would exist for a completelycustom orthopedic implant. The surgeon would experiment with certainconfigurations of the respective trial components and take in vivo dataon each configuration. Obviously, experience of the surgeon plays asignificant role in which combinations of configurations are chosenbased upon the anatomy of the patient. The computer interface with itsexperience from prior cases could also help suggest modular combinationthat optimize function. After the surgeon is satisfied that a preferredconfiguration has been obtained, the surgeon would record theparticulars of the trials and have each orthopedic implant rapidmanufactured. As discussed previously, when using a reconfigurabletrial, the shape of each trial component (such as the tibial post trial)is given a unique identifier that allows a computer to build a virtual3D model of the permanent orthopedic implant that is sent to the rapidmanufacturing machine for fabrication.

It is also within the scope of the invention for the surgeon to finalizethe orientation of the elements of a reconfigurable trial and then havethe trial laser scanned. The output data from the laser scan is used togenerate a virtual 3D model that is sent onto the rapid manufacturingmachine for fabrication of the permanent orthopedic implant. Anexemplary laser scanner for scanning the reconfigurable trial includesthe Surveyor RE-Series 3D laser scanners commercially available fromLaser Design, Inc., Minneapolis, Minn. (www.laserdesign.com).

It is also within the scope of the invention to use new imagingtechnologies, such as ultrasound imaging, and x-ray or fluoroscopyimaging to create a 3D bone model The created bone model can beregistered in real space with the actual bone. Trial implants can beplace on the real bone such that the implants and the bone can be takenthough a range of motion then tracked using known optical imagingtechniques. Exemplary tracking methods are disclosed in U.S. PatentPublication Nos. 20060293582A1; US20060173268A1; and US20050261571A1.

Information gathered from tracking the bone can be compared to adatabase of kinematic or other clinically significant information tomake determinations about different implants, different implant brands,or different implant designs. For example, after a first effort withimplant trials a surgeon may decide to use a different brand or size ofmedical implant. Alternatively, engineers may use information gatheredfrom the comparison to make design determinations regarding implants asdescribed herein.

Following from the above description and invention summaries, it shouldbe apparent to those of ordinary skill in the art that, while themethods and apparatuses herein described constitute exemplaryembodiments of the present invention, the invention contained herein isnot limited to this precise embodiment and that changes may be made tosuch embodiments without departing from the scope of the invention asdefined by the claims. Additionally, it is to be understood that theinvention is defined by the claims and it is not intended that anylimitations or elements describing the exemplary embodiments set forthherein are to be incorporated into the interpretation of any claimelement unless such limitation or element is explicitly stated.Likewise, it is to be understood that it is not necessary to meet any orall of the identified advantages or objects of the invention disclosedherein in order to fall within the scope of any claims, since theinvention is defined by the claims and since inherent and/or unforeseenadvantages of the present invention may exist even though they may nothave been explicitly discussed herein.

What is claimed is:
 1. A reconfigurable orthopedic implant trialcomprising: a first orthopedic component including a first sensor on anarticulating surface thereof; a second orthopedic component including asecond sensor on an articulating surface thereof, the second orthopediccomponent configured to be removably mounted with the first orthopediccomponent; a third orthopedic component including a third sensor on anarticulating surface thereof, the third orthopedic component configuredto be removably mounted with to the first orthopedic component; whereinthe first sensor, the second sensor and the third sensor are configuredto generate kinematic data.
 2. The reconfigurable orthopedic implanttrial of claim 1, wherein: the first orthopedic component comprises atleast one of a tibial tray and a tibial tray insert; the secondorthopedic component includes a first tibial post; and the thirdorthopedic component includes a second tibial post; the first tibialpost differs from the second tibial post in at least one of size, shape,and material composition.
 3. The reconfigurable orthopedic implant trialof claim 2, wherein the at least one of a tibial tray and a tibial trayinsert of the first orthopedic component includes a plurality oforifices at different locations therein, the orifices configured forreceiving a tibial post.
 4. The reconfigurable orthopedic implant trialof claim 3 wherein at least one of the tibial posts is configured forbeing locked with respect to the first orthopedic component to inhibitrotation.
 5. The reconfigurable orthopedic implant trial of claim 1,wherein: the first orthopedic component comprises at least one of atibial tray and a tibial tray insert; the second orthopedic componentincludes a first condyle receiver; and the third orthopedic componentincludes a second condyle receiver.
 6. The reconfigurable orthopedicimplant trial of claim 5 further comprising at least one condyleconfigured for being received by one of the first and second condylereceivers.
 7. The reconfigurable orthopedic implant trial of claim 6wherein the at least one condyle includes at least one condyle cutoutand at least one condyle insert removably mounted in the at least onecondyle cutout.
 8. The reconfigurable orthopedic implant trial of claim5 wherein the first condyle receiver has a different shape from thesecond condyle receiver.
 9. The reconfigurable orthopedic implant trialof claim 5 wherein the first condyle receiver differs from the secondcondyle receiver in at least one of depth, angle and length.
 10. Thereconfigurable orthopedic implant trial of claim 5 wherein at least oneof the first condyle receiver and second condyle receiver are formedfrom multiple portions that make up the respective condyle receiver. 11.The reconfigurable orthopedic implant trial of claim 1, furthercomprising: a computer communicatively coupled to at least one of thesecond sensor of the second component and the third sensor of the thirdcomponent; and a database including fabrication instructions forcreating and integrating at least one of the first and second orthopediccomponents without the first and second sensors, and the first and thirdorthopedic components without the first and third sensors.
 12. Areconfigurable orthopedic implant trial comprising: a first orthopediccomponent comprising at least one of a tibial tray and a tibial trayinsert; a first sensor on an articulating surface of the firstorthopedic component; a plurality of second orthopedic components, thesecond orthopedic components including a plurality of tibial posts, eachtibial post configured to be removably mounted with the first orthopediccomponent; a second sensor on an articulating surface of at least one ofthe plurality of second orthopedic components; the tibial posts of theplurality differing from each other in at least one of size, shape, andmaterial composition; the first sensor and the second sensor configuredfor generating kinematic data.
 13. The reconfigurable orthopedic implanttrial of claim 12, wherein the least one of a tibial tray and a tibialtray insert of the first orthopedic component includes a plurality oforifices at different locations therein, the orifices configured forreceiving a tibial post.
 14. The reconfigurable orthopedic implant trialof claim 12 wherein at least one of the tibial posts is configured forbeing locked with respect to the first orthopedic component to inhibitrotation.
 15. A reconfigurable orthopedic implant trial comprising: afirst orthopedic component comprising at least one of a tibial tray anda tibial tray insert; a first sensor on an articulating surface of thefirst orthopedic component; a plurality of second orthopedic components,the second orthopedic components including a plurality of condylereceivers, each condyle receiver configured to be removably mounted withthe first orthopedic component; a second sensor on an articulatingsurface of at least one of the plurality of second orthopediccomponents; the first sensor and the second sensor configured forgenerating kinematic data.
 16. The reconfigurable orthopedic implanttrial of claim 15 further comprising at least one condyle configured forbeing received by one of the plurality of condyle receivers.
 17. Thereconfigurable orthopedic implant trial of claim 16 wherein the at leastone condyle includes at least one condyle cutout and at least onecondyle insert removably mounted in the at least one condyle cutout. 18.The reconfigurable orthopedic implant trial of claim 15 wherein theplurality of condyle receivers differ in shape.
 19. The reconfigurableorthopedic implant trial of claim 15 wherein the plurality of condylereceivers differ in at least one of depth, angle and length.
 20. Thereconfigurable orthopedic implant trial of claim 15 wherein theplurality of condyle receivers are formed from multiple portions thatmake up the respective condyle receiver.